CLASS III Drug recall · Reported 22 Mar 2023 · FDA Enforcement Report
Buprenorphine Transdermal System, CIII 20 mcg/hour recalled
Aveva Drug Delivery Systems is recalling Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of, distributed nationwide in the US. The recall was initiated on 15 Feb 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0466-2023
- FDA event ID
- 91712
- Recalling firm
- Aveva Drug Delivery Systems, Miramar, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Feb 2023
- FDA classified
- 14 Mar 2023
- Reported
- 22 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Feb 2023 | Recall initiated by company | |
| 14 Mar 2023 | Classified by FDA | +27 days |
| 22 Mar 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Which lots are affected?
Lot#: 51836 Exp: 07/2023
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91712| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Buprenorphine Transdermal System, CIII 10 mcg/hour recalled | Aveva Drug Delivery Systems | Potency & Assay | Nationwide |
More recalls from Aveva Drug Delivery Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nicotine Transdermal System Patch, 14 mg, 14 patches per, Aveva recalledNicotine | Aveva Drug Delivery Systems | Potency & Assay | Nationwide |
| Drug | CLASS III | Buprenorphine Transdermal System, CIII 10 mcg/hour recalled | Aveva Drug Delivery Systems | Potency & Assay | Nationwide |
Other Buprenorphine Transdermal System recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Transdermal System, CIII 10 mcg/hour recalled | Aveva Drug Delivery Systems | Potency & Assay | Nationwide |